Perineuraxial Anesthesia Fluid Management and Infant Neurobehaviors (PAFUMIN)

Correlation Between Perineuraxial Anesthesia Fluid Resuscitation in Cesarean Section and Infant Neurobehaviors

Early change in neurobehavior is strongly associated with the intelligence development of children. Previous studies reported that cesarean section itself could influence the later development of children. In addition, neuraxial anesthesia including epidural, spinal and combined spinal epidural anesthesia (CSEA) are the major forms used during cesarean delivery, and these anesthesia techniques will undoubtedly evoke hypotension and corresponding hemodynamic alteration, of which would result in decreasing in umbilical placental insufficiency and fetus hypoxia leading to early abnormality of neurobehaviors in infants. Fluid management, such as crystalloid and colloid, is the common ones given before or / and after neuraxial anesthesia to prevent or reverse hypotension. However, it is still unknown whether the perineuraxial anesthesia fluid resuscitation could improve the neurobehavior scorings, and could produce positive effect on later intelligence development. Herein the investigators hypothesized that effective perineuraxial anesthesia fluid management during cesarean section would prevent the occurrence of hypotension and improve infant's neurobehavior scorings.

Study Overview

• Status: Completed
• Conditions: Cesarean Section
• Intervention / Treatment: Drug: Ringer's Lactate; Drug: Six percent hydroxyethyl starch

• Study Type: Interventional
• Enrollment (Actual): 5000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210004
      • The Affiliated Nanjing Maternity and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 21-40 yr
• First time of delivery
• ASA status I-II
• No premature
• No genetic and infectious diseases
• Chinese

Exclusion Criteria:

• < 21 yr
• > 40 yr
• Subjects with cardiac and pulmonary disorders
• Dislocation of placenta
• Pregnant hypertension
• Allergy to local anesthetics
• Unwilling to cooperation
• With significant delivery side effects

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Crystalloid resuscitation; Crystalloid (Ringer's lactate) will be delivered before (15min) or after (15min) neuraxial anesthesia	Drug: Ringer's Lactate; Ringer's Lactate 8 ml/kg was given intravenously before or after epidural, spinal or CSEA in cesarean section; Other Names: Lactated Ringer's solution
ACTIVE_COMPARATOR: Colloid resuscitation; Colloid (6% hydroxyethyl starch ) will be delivered before (15min) or after (15min) neuraxial anesthesia	Drug: Six percent hydroxyethyl starch; Hydroxyethyl starch (6%) was given before or after epidural, spinal or CSEA in cesarean section; Other Names: HES/HAES

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	Immediate after birth (0 min)

Secondary Outcome Measures

Outcome Measure	Time Frame
Apgar scoring	One min and 5min after birth.
Umbilical-cord gases analysis	At the time baby was born (0min)
Neonatal sepsis evaluation	One hour after the baby was born
Neonatal antibiotic treatment	One hour after the baby was born
Incidence of maternal side effects	Analgesia initiation (0min) to successful vaginal delivery (this time encountered alteration with different women)
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	30min after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	1h after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	8h after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	1d after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	1wk after birth
Neurobehavior evaluation with the Assessment of Preterm Infants' Behavior (APIB)	1month after birth

Collaborators and Investigators

• Sponsor: Nanjing Medical University

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ACTUAL): May 1, 2011
• Study Completion (ACTUAL): May 1, 2011

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (ESTIMATE): October 1, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): July 27, 2011
• Last Update Submitted That Met QC Criteria: July 26, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Development; Neurobehavior; Fluid management; Neuraxial anesthesia
• Other Study ID Numbers: NJMU-0932MZ; NMUK2190